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Infusion Pump, Drug Specific, Pharmacy-Filled

FDA product code QJY · 4 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5725
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-02-21 – 2024-11-27

A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.

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